To find out which drug is better between Midazolam versus Fentanyl when used as an adjuvant with 0.5% hyperbaric Levobupivacaine in achieving prolonged post operative pain relief in patients undergoing elective lower limb surgeries under spinal anesthesia

Comparative study on analgesic efficacy of Midazolam versus Fentanyl as an adjuvant to 0.5% hyperbaric levobupivacaine in spinal anesthesia for patients undergoing elective lower limb surgeries a randomized interventional study at SMS medical college Jaipur - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057342

Enrollment

Registered

2023-09-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Spinal anesthesia with 0.5% Hyperbaric Levobupivacaine with midazolam as adjuvant.: Spinal anesthesia given with 0.5% Hyperbaric Levobupivacaine 10 mg in 2 ml with 2.5 mg Midazolam in 0

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient willing to participate in the study with written informed consent 2. Patients age between 20 to 60 years 3. Height of the patient is more than 145 cms 4. Patients undergoing elective lower limb surgeries 5. Patients belonging to ASA physical status I or II

Exclusion criteria

Exclusion criteria: 1. Patients with bacteremia sepsis or skin infection of local site 2. Patient with severe hypovolemia or anemia or compromised renal cardiac or respiratory status 3. Patients with raised intracranial tension 4. Patients with abnormal coagulation profile 5. Patients allergic to drugs used for study 6. Uncooperative patients 7. Patients in whom spinal anesthesia failed and general anesthesia was required

Design outcomes

Primary

Measure	Time frame
To determine the average time for the need of first dose of rescue analgesiaTimepoint: Every 30 minutes for 6 hours postoperatively	—

Secondary

Measure	Time frame
Adverse events if any to be notedTimepoint: 24 hours;To compare the changes in cardiocirculatory parameters ( HR, SBP, DBP, MBP)Timepoint: Every 5 minutes for first 30 minutes followed by every 10 minutes till completion of surgery then every 30 minutes for 6 hours postoperatively;To determine the average duration of motor blockTimepoint: Every 30 minutes till 6 hours postoperatively;To determine the average duration of sensory blockTimepoint: Every 30 minutes till 6 hours postoperatively;To determine the average time for the onset of motor blockTimepoint: Every 2 minutes till maximum motor block;To determine the average time for the onset of sensory blockTimepoint: Every 2 minutes till highest level attained;To determine the VAS scoreTimepoint: Every 30 minutes for 6 hours postoperatively	—

Measure

Time frame

Adverse events if any to be notedTimepoint: 24 hours;To compare the changes in cardiocirculatory parameters ( HR, SBP, DBP, MBP)Timepoint: Every 5 minutes for first 30 minutes followed by every 10 minutes till completion of surgery then every 30 minutes for 6 hours postoperatively;To determine the average duration of motor blockTimepoint: Every 30 minutes till 6 hours postoperatively;To determine the average duration of sensory blockTimepoint: Every 30 minutes till 6 hours postoperatively;To determine the average time for the onset of motor blockTimepoint: Every 2 minutes till maximum motor block;To determine the average time for the onset of sensory blockTimepoint: Every 2 minutes till highest level attained;To determine the VAS scoreTimepoint: Every 30 minutes for 6 hours postoperatively

—

Countries

India

Contacts

Public ContactDR Harita Haridas

S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS

drsonalisms@gmail.com9214540552

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026